Q2BI

Q2BI, Corp. is a biometrical and clinical science contract research organization (CRO) for life science product/drug development and regulatory submissions, with a broad range of expertise-based services in the areas of electronic data capture (EDC), clinical data management (CDM), Medical Coding (MC), Statistical Programming, Biostatistical Sciences, Medical Writing, Safety Monitoring including IDMC/DSMB, Pharmacokinetics / Pharmacodynamics (PK/PD), Data Visualization and System Validation Consulting since 2009.

Q2BI covers all clinical phase studies as well as regulatory submission-needed Biostatistics/Programming/Data Management (BPDM) services. Q2BI as a global CRO has grown steadily over years with long-term service and partnerships with many well-established as well as newly emerged companies in life sciences. Headquartered in the Boston area with offices in Princeton, NJ and San Francisco Bay Area, Australia (Melbourne) and China (with a footprint in Guangzhou, greater Shanghai and greater Beijing metro areas), Q2BI has won its reputation for its high quality, flexibility, excellent service and harmonized collaborations in meeting the needs and achieving the expectations for sponsors of varying sizes.

Q2BI team has experience in over 1,500 studies and 38 successful NDA/BLA submission approvals in various therapeutic areas with the FDA as well as submission experiences with the EMA, MFDS in South Korea, NMPA/CFDA in China, TGA in Australia and PMDA in Japan among many other global regulatory agencies. Q2BI is a pioneer in adopting CDISC and our team supported the world first FDA Project ORBIS.

At Q2BI, we put great endeavor in helping, understanding and meeting the scientific aspects of any in-contract development project, with priority focus on high quality of our work and deliverables. We trust our employees are the greatest talent and asset, who are provided with unique, project sponsors-based business owner (BO) system and project-team setting for daily performances and demonstrations. We welcome the opportunity to meet and partner with your organization.